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Cardiovascular DiseasesPhase 2WAFACSNCT00000541

Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

A Phase 2 study testing dietary supplements, vitamin C and vitamin E in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in high risk women with a prior history of atherosclerotic cardiovascular disease. Read more about this study

Who is it for?
Ages 40 years and older, women only
What is being tested?
dietary supplements, vitamin C and vitamin E
How many people
Not given
Where
No sites listed yet
Study dates
May 1993to Jul 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.

About this study

To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and aspirin in a low risk population of women.

Read the detailed description

The Women's Antioxidant and Folic Acid Cardiovascular Study tested the effects of vitamin C (500 mg/day), vitamin E (600 IU every other day), and/or beta carotene (50 mg every other day) on the risk of major cardiovascular events (a combined outcome of myocardial infarction, stroke, coronary revascularization, or cardiovascular death) among 8171 female health professionals at increased risk. Participants were 40 years or older with a history of cardiovascular disease or 3 or more cardiovascular risk factors and were followed for an average duration of 9.4 years, from 1995-1996 to 2005. In 1998, 5442 of these participants were further randomized to the B-vitamin intervention (a daily combination pill containing folic acid [2.5 mg], vitamin B6 [50 mg], vitamin B12 [1 mg]) and were followed for 7.3 years, from April 1998 through July 2005.

Being tested
dietary supplements, vitamin C, vitamin E, beta-carotene, folic acid/Vitamin B6/Vitamin B12
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietary supplementsBehavioural

  • vitamin CDrug

  • vitamin EDrug

  • beta-caroteneDrug

  • folic acid/Vitamin B6/Vitamin B12Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular disease

  2. Cancer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startMay 1993
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000541
Sponsor's protocol ID
84
Other IDs
R01HL046959
Acronym
WAFACS
Status last verified
Jul 2020
First submitted
27 Oct 1999
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Manson JE, Gaziano JM, Spelsberg A, Ridker PM, Cook NR, Buring JE, Willett WC, Hennekens CH. A secondary prevention trial of antioxidant vitamins and cardiovascular disease in women. Rationale, design, and methods. The WACS Research Group. Ann Epidemiol. 1995 Jul;5(4):261-9. doi: 10.1016/1047-2797(94)00091-7.

    PubMed 8520707

  • Mason PJ, Manson JE, Sesso HD, Albert CM, Chown MJ, Cook NR, Greenland P, Ridker PM, Glynn RJ. Blood pressure and risk of secondary cardiovascular events in women: the Women's Antioxidant Cardiovascular Study (WACS). Circulation. 2004 Apr 6;109(13):1623-9. doi: 10.1161/01.CIR.0000124488.06377.77. Epub 2004 Mar 15.

    PubMed 15023883

  • Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. J Womens Health (Larchmt). 2004 Jan-Feb;13(1):99-117. doi: 10.1089/154099904322836519.

    PubMed 15006283

  • Cook NR, Albert CM, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study. Arch Intern Med. 2007 Aug 13-27;167(15):1610-8. doi: 10.1001/archinte.167.15.1610.

    PubMed 17698683

  • Zhang SM, Cook NR, Albert CM, Gaziano JM, Buring JE, Manson JE. Effect of combined folic acid, vitamin B6, and vitamin B12 on cancer risk in women: a randomized trial. JAMA. 2008 Nov 5;300(17):2012-21. doi: 10.1001/jama.2008.555.

    PubMed 18984888

  • Kang JH, Cook N, Manson J, Buring JE, Albert CM, Grodstein F. A trial of B vitamins and cognitive function among women at high risk of cardiovascular disease. Am J Clin Nutr. 2008 Dec;88(6):1602-10. doi: 10.3945/ajcn.2008.26404.

    PubMed 19064521

  • Albert CM, Cook NR, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE. Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial. JAMA. 2008 May 7;299(17):2027-36. doi: 10.1001/jama.299.17.2027.

    PubMed 18460663

  • Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2.

    PubMed 19491386

  • Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial. Diabetes. 2009 Aug;58(8):1921-8. doi: 10.2337/db09-0087. Epub 2009 Jun 2.

    PubMed 19491213

  • Lin J, Cook NR, Albert C, Zaharris E, Gaziano JM, Van Denburgh M, Buring JE, Manson JE. Vitamins C and E and beta carotene supplementation and cancer risk: a randomized controlled trial. J Natl Cancer Inst. 2009 Jan 7;101(1):14-23. doi: 10.1093/jnci/djn438. Epub 2008 Dec 30.

    PubMed 19116389

  • Kang JH, Cook NR, Manson JE, Buring JE, Albert CM, Grodstein F. Vitamin E, vitamin C, beta carotene, and cognitive function among women with or at risk of cardiovascular disease: The Women's Antioxidant and Cardiovascular Study. Circulation. 2009 Jun 2;119(21):2772-80. doi: 10.1161/CIRCULATIONAHA.108.816900. Epub 2009 May 18.

    PubMed 19451353

  • Christen WG, Glynn RJ, Chew EY, Albert CM, Manson JE. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women's Antioxidant and Folic Acid Cardiovascular Study. Arch Intern Med. 2009 Feb 23;169(4):335-41. doi: 10.1001/archinternmed.2008.574.

    PubMed 19237716

  • Song Y, Manson JE, Lee IM, Cook NR, Paul L, Selhub J, Giovannucci E, Zhang SM. Effect of combined folic acid, vitamin B(6), and vitamin B(12) on colorectal adenoma. J Natl Cancer Inst. 2012 Oct 17;104(20):1562-75. doi: 10.1093/jnci/djs370. Epub 2012 Oct 12.

    PubMed 23066166

  • Aday AW, Duran EK, Van Denburgh M, Kim E, Christen WG, Manson JE, Ridker PM, Pradhan AD. Homocysteine Is Associated With Future Venous Thromboembolism in 2 Prospective Cohorts of Women. Arterioscler Thromb Vasc Biol. 2021 Jul;41(7):2215-2224. doi: 10.1161/ATVBAHA.121.316397. Epub 2021 May 27.

    PubMed 34039021

  • Christen WG, Cook NR, Van Denburgh M, Zaharris E, Albert CM, Manson JE. Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. J Am Heart Assoc. 2018 May 18;7(11):e008517. doi: 10.1161/JAHA.117.008517.

    PubMed 29776960

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dietary supplements, vitamin C and vitamin E in people with Cardiovascular Diseases and Coronary Arteriosclerosis, run by Brigham and Women's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular disease. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000541, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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